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Chitin is an abundant waste product from shrimp and mushroom industries and as such, an appropriate secondary feedstock for biotechnological processes. However, chitin is a crystalline substrate embedded in complex biological matrices, and, therefore, difficult to utilize, requiring an equally complex chitinolytic machinery. Following a bottom-up approach, we here describe the step-wise development of a mutualistic, non-competitive consortium in which a lysine-auxotrophic Escherichia coli substrate converter cleaves the chitin monomer N-acetylglucosamine (GlcNAc) into glucosamine (GlcN) and acetate, but uses only acetate while leaving GlcN for growth of the lysine-secreting Corynebacterium glutamicum producer strain. We first engineered the substrate converter strain for growth on acetate but not GlcN, and the producer strain for growth on GlcN but not acetate. Growth of the two strains in co-culture in the presence of a mixture of GlcN and acetate was stabilized through lysine cross-feeding. Addition of recombinant chitinase to cleave chitin into GlcNAc2, chitin deacetylase to convert GlcNAc2 into GlcN2 and acetate, and glucosaminidase to cleave GlcN2 into GlcN supported growth of the two strains in co-culture in the presence of colloidal chitin as sole carbon source. Substrate converter strains secreting a chitinase or a β-1,4-glucosaminidase degraded chitin to GlcNAc2 or GlcN2 to GlcN, respectively, but required glucose for growth. In contrast, by cleaving GlcNAc into GlcN and acetate, a chitin deacetylase-expressing substrate converter enabled growth of the producer strain in co-culture with GlcNAc as sole carbon source, providing proof-of-principle for a fully integrated co-culture for the biotechnological utilization of chitin.
A brief questionnaire for measuring alarm fatigue in nurses and physicians in intensive care units
(2023)
When exposed to hundreds of medical device alarms per day, intensive care unit (ICU) staff can develop “alarm fatigue” (i.e., desensitisation to alarms). However, no standardised way of quantifying alarm fatigue exists. We aimed to develop a brief questionnaire for measuring alarm fatigue in nurses and physicians. After developing a list of initial items based on a literature review, we conducted 15 cognitive interviews with the target group (13 nurses and two physicians) to ensure that the items are face valid and comprehensible. We then asked 32 experts on alarm fatigue to judge whether the items are suited for measuring alarm fatigue. The resulting 27 items were sent to nurses and physicians from 15 ICUs of a large German hospital. We used exploratory factor analysis to further reduce the number of items and to identify scales. A total of 585 submissions from 707 participants could be analysed (of which 14% were physicians and 64% were nurses). The simple structure of a two-factor model was achieved within three rounds. The final questionnaire (called Charité Alarm Fatigue Questionnaire; CAFQa) consists of nine items along two scales (i.e., the “alarm stress scale” and the “alarm coping scale”). The CAFQa is a brief questionnaire that allows clinical alarm researchers to quantify the alarm fatigue of nurses and physicians. It should not take more than five minutes to administer.
Background
A peripheral venous catheter (PVC) is the most widely used device for obtaining vascular access, allowing the administration of fluids and medication. Up to 25% of adult patients, and 50% of pediatric patients experience a first-attempt cannulation failure. In addition to patient and clinician characteristics, device features might affect the handling and success rates. The objective of the study was to compare the first-attempt cannulation success rate between PVCs with wings and a port access (Vasofix® Safety, B. Braun, abbreviated hereon in as VS) with those without (Introcan® Safety, B. Braun, abbreviated hereon in as IS) in an anesthesiological cohort.
Methods
An open label, multi-center, randomized trial was performed. First-attempt cannulation success rates were examined, along with relevant patient, clinician, and device characteristics with univariate and multivariate analyses. Information on handling and adherence to use instructions was gathered, and available catheters were assessed for damage.
Results
Two thousand three hundred four patients were included in the intention to treat analysis. First-attempt success rate was significantly higher with winged and ported catheters (VS) than with the non-winged, non-ported design (IS) (87.5% with VS vs. 78.2% with IS; PChi < .001). Operators rated the handling of VS as superior (rating of “good” or “very good: 86.1% VS vs. 20.8% IS, PChi < .001). Reinsertion of the needle into the catheter after partial withdrawal—prior or during the catheterization attempt—was associated with an increased risk of cannulation failure (7.909, CI 5.989–10.443, P < .001 and 23.023, CI 10.372–51.105, P < .001, respectively) and a twofold risk of catheter damage (OR 1.999, CI 1.347–2.967, P = .001).
Conclusions
First-attempt cannulation success of peripheral, ported, winged catheters was higher compared to non-ported, non-winged devices. The handling of the winged and ported design was better rated by the clinicians. Needle reinsertions are related to an increase in rates of catheter damage and cannulation failure.
A comparison study on modeling of clustered and overdispersed count data for multiple comparisons
(2021)
Data collected in various scientific fields are count data. One way to analyze such data is to compare the individual levels of the factor treatment using multiple comparisons. However, the measured individuals are often clustered – e.g. according to litter or rearing. This must be considered when estimating the parameters by a repeated measurement model. In addition, ignoring the overdispersion to which count data is prone leads to an increase of the type one error rate. We carry out simulation studies using several different data settings and compare different multiple contrast tests with parameter estimates from generalized estimation equations and generalized linear mixed models in order to observe coverage and rejection probabilities. We generate overdispersed, clustered count data in small samples as can be observed in many biological settings. We have found that the generalized estimation equations outperform generalized linear mixed models if the variance-sandwich estimator is correctly specified. Furthermore, generalized linear mixed models show problems with the convergence rate under certain data settings, but there are model implementations with lower implications exists. Finally, we use an example of genetic data to demonstrate the application of the multiple contrast test and the problems of ignoring strong overdispersion.
Objectives
Cervical movement impairment has been identified as a core component of cervicogenic headache evaluation. However, normal range of motion values in children has been investigated rarely and no study has reported such values for the flexion–rotation test (FRT). The purpose of this study was to identify normal values and side-to-side variation for cervical spine range of motion (ROM) and the FRT, in asymptomatic children aged 6–12 years. Another important purpose was to identify the presence of pain during the FRT.
Methods
Thirty-four asymptomatic children without history of neck pain or headache (26 females and 8 males, mean age 125.38 months [SD 13.14]) were evaluated. Cervical spine cardinal plane ROM and the FRT were evaluated by a single examiner using a cervical ROM device.
Results
Values for cardinal plane ROM measures are presented. No significant gender difference was found for any ROM measure. Mean difference in ROM for rotation, side flexion, and the FRT were less than one degree. However, intra-individual variation was greater, with lower bound scores of 9.32° for rotation, 5.30° for side flexion, and 10.89° for the FRT. Multiple linear regression analysis indicates that movement in the cardinal planes only explains 19% of the variance in the FRT. Pain scores reported following the FRT were less than 2/10.
Discussion
Children have consistently greater cervical spine ROM than adults. In children, side-to-side variation in rotation and side flexion ROM and range recorded during the FRT indicates that the clinician should be cautious when using range in one direction to determine impairment in another. Range recorded during the FRT is independent of cardinal movement variables, which further adds to the importance of the FRT, as a test that mainly evaluates range of movement of the upper cervical spine.
Currently, the treatment of musicians is an interprofessional approach. Playing-related health complaints may impact the performance of a musician. In Germany, a medical consulting hour for musicians exists, but those for athletes in sports medicine are not so common. The diagnosing and treatment procedure within the physiotherapy consultation for musicians follows a specific concept-b and requires knowledge of instruments and musician-specific complaints. Based on the consulting hour in a clinic in Osnabrueck, 614 case reports were part of this sample, of which 558 data sets were complete. The focus of the analysis is the instrument and the primary complaint. Also, the type of therapy is characterized, and the amount is calculated. Primary complaints of musicians, in general, are found most frequently in the spine and upper extremity. Musician complaints are different between instruments. Instrumentalists have a significantly higher chance to suffer from a primary complaint in the area of the upper extremity. Furthermore, the groups without an instrument (e.g., singing or dancing) are developing complaints in the anatomical area which they primarily use. Therefore, these types of therapy were used: physiotherapy, manual therapy, and osteopathy with an average of 5.9 treatment units. This study underpinned the importance of musician-specific physiotherapy as a profession to treat musicians. Also, an interdisciplinary approach is necessary to treat all aspects of complaints.
The objective of this review is a global assessment of the economics of second‐generation biorefineries, with a focus on the use of food waste and agricultural residues for chemical production by applying biotechnological processes. Analyses are conducted on feedstock and product distribution, applied economic models, and profitability figures for the period 2013–2018. In a study of 163 articles on different biorefinery systems, the production of chemicals is identified as the second major product class, after bioenergy. Bagasse and straw are frequently analyzed second‐generation feedstocks. Based on the evaluation of 22 articles, second‐generation biorefineries producing chemicals by applying biotechnological processes proves to be economically feasible. On average, both the internal rate of return (IRR) and the return on investment (ROI) are 20% and the payback period (PP) is 6 years. The cost share of feedstock in biorefineries is between 0–50%. The price of the end product and the fermentation yields have the most impact on profitability. The processing of food waste that has industrial and municipal origins appears more economical than the processing of agricultural residues. Scientists, policy makers and entrepreneurs with an appropriate risk tolerance are advised to pay particular attention to municipal food waste and the potential economic production of carboxylic acids. For various economic issues related to biorefineries, dynamic‐deterministic models are recommended, which can be extended by a stochastic model. This review provides an initial overview of the economic feasibility of second‐generation biorefineries. Further techno‐economic analyses are required to produce statistically significant statements on key profitability figures. © 2020 The Authors. Biofuels, Bioproducts, and Biorefining published by Society of Chemical Industry and John Wiley & Sons, Ltd.
Business-driven development favors the construction of process models
at different abstraction levels and by different people. As a consequence, there is a demand for consolidating different versions of process models by merging them. In this paper, we study a basic scenario, derive requirements and present a prototype for detecting and resolving changes between process models.
Transport operations are climate sensitive. Despite this, scientific literature and corporate practice present little evidence on how corporate actors use climate adaptation measures to prepare their transport operations for climate change. This paper explores two research questions: How can the acceptance among corporate decision-makers towards climate adaptation measures for their transport operations be explained? Based on the Theory of Planned Behavior and the Diffusion of Innovations we develop a theoretical framework for dealing with climate adaptation measures for transport operations (step 1). We support the use of this framework through a literature review (1989–2020) (step 2) and semi-structured interviews with German companies that have implemented best practice measures (step 3). The results show that the handling of climate adaptation measures for transport operations can be described in three acceptance phases: acceptance of attitude, action, and use. We conclude that these phases determine the approaches required for promoting climate change adaptation.
Objective:
To compare the short- and long-term effects of a structural-oriented (convential) with an activity-oriented physiotherapeutic treatment in patients with frozen shoulder.
Design:
Double-blinded, randomized, experimental study.
Setting:
Outpatient clinic.
Subjects:
We included patients diagnosed with a limited range of motion and pain in the shoulder region, who had received a prescription for physiotherapy treatment, without additional symptoms of dizziness, a case history of headaches, pain and/or limited range of motion in the cervical spine and/or temporomandibular joint.
Interventions:
The study group received treatment during the performance of activities. The comparison group was treated with manual therapy and proprioceptive neuromuscular facilitation (conventional therapy). Both groups received 10 days of therapy, 30 minutes each day.
Main measures:
Range of motion, muscle function tests, McGill pain questionnaire and modified Upper Extremity Motor Activity Log were measured at baseline, after two weeks of intervention and after a three-month follow-up period without therapy.
Results:
A total of 66 patients were randomized into two groups: The activity-oriented group (n = 33, mean = 44 years, SD = 16 years) including 20 male (61%) and the structural-oriented group (n = 33, mean = 47 years, SD = 17 years) including 21 male (64%). The activity-oriented group revealed significantly greater improvements in the performance of daily life activities and functional and structural tests compared with the group treated with conventional therapy after 10 days of therapy and at the three-month follow-up (p < 0.05).
Conclusions:
Therapy based on performing activities seems to be more effective for pain reduction and the ability to perform daily life activities than conventional treatment methods.
Adaptivity is prevalent in today’s software. Mobile devices
self-adapt to available network connections, washing machines
adapt to the amount of laundry, etc. Current approaches for engineering such systems facilitate the specification of adaptivity in the analysis and the technical design. However, the modeling of platform independent models for adaptivity in the logical design phase remains rather neglected causing a gap between the analysis and the technical design phase.
To overcome this situation, we propose an approach called Adapt Cases. Adapt Cases allow the explicit modeling of adaptivity with domain-specific means, enabling adaptivity to gather attention early in the software engineering process.
Since our approach is based on the concept of use cases it
is easy adoptable in new and even running projects that
use the UML as a specification language, and additionally,
can be easily incorporated into model-based development
environments.
During gestation, the most drastic change in oxygen supply occurs with the onset of ventilation after birth. As the too early exposure of premature infants to high arterial oxygen pressure leads to characteristic diseases, we studied the adaptation of the oxygen sensing system and its targets, the hypoxia-inducible factor- (HIF-) regulated genes (HRGs) in the developing lung. We draw a detailed picture of the oxygen sensing system by integrating information from qPCR, immunoblotting, in situ hybridization, and single-cell RNA sequencing data in ex vivo and in vivo models. HIF1α protein was completely destabilized with the onset of pulmonary ventilation, but did not coincide with expression changes in bona fide HRGs. We observed a modified composition of the HIF-PHD system from intrauterine to neonatal phases: Phd3 was significantly decreased, while Hif2a showed a strong increase and the Hif3a isoform Ipas exclusively peaked at P0. Colocalization studies point to the Hif1a-Phd1 axis as the main regulator of the HIF-PHD system in mouse lung development, complemented by the Hif3a-Phd3 axis during gestation. Hif3a isoform expression showed a stepwise adaptation during the periods of saccular and alveolar differentiation. With a strong hypoxic stimulus, lung ex vivo organ cultures displayed a functioning HIF system at every developmental stage. Approaches with systemic hypoxia or roxadustat treatment revealed only a limited in vivo response of HRGs. Understanding the interplay of the oxygen sensing system components during the transition from saccular to alveolar phases of lung development might help to counteract prematurity-associated diseases like bronchopulmonary dysplasia.
The increased consumption of reduced-fat or non-fat products leads to a reduced intake of fat-soluble bioactive substances, such as fat-soluble vitamins. Due to their natural role as transport systems for hydrophobic substances, casein micelles (CM) might depict a viable system. The structure of CM is characterized by a lipophilic core stabilized by an electric double layer-like structure. Modification allows accessibility of the core and, therefore, the inclusion of fat-soluble bioactive substances. Well-known modifications are pH reduction and use of rennet enzyme. A completely new procedure to modify CM structure is offered by pulsed electrical fields (PEF). The principle behind PEF is called electroporation and affects the electric double layer of CM so that it is interrupted. In this way, lipophilic substances can be incorporated into CM. In this work, we evaluated integration of β-carotene into native CM by an industry-compatible process to overcome disadvantages associated with the use of Na-caseinate and avoid great technical effort, e.g., due to treatment with high hydrostatic pressure. Our research has shown that PEF can be used for disintegration of CM and that significant amounts of β-carotene can be incorporated in CM. Furthermore, after disintegration using PEF, a combination of another PEF and thermal treatment was applied to restructure CM and trap significant amounts of β-carotene, permanently, ending up with an encapsulation efficiency of 78%.
Introduction: Patients undergoing revision total hip surgery (RTHS) have a high prevalence of mild and moderate preoperative anemia, associated with adverse outcomes. The aim of this study was to investigate the association of perioperative allogeneic blood transfusions (ABT) and postoperative complications in preoperatively mild compared to moderate anemic patients undergoing RTHS who did not receive a diagnostic anemia workup and treatment before surgery. Methods: We included 1,765 patients between 2007 and 2019 at a university hospital. Patients were categorized according to their severity of anemia using the WHO criteria of mild, moderate, and severe anemia in the first Hb level of the case. Patients were grouped as having received no ABT, 1–2 units of ABT, or more than 2 units of ABT. Need for intraoperative ABT was assessed in accordance with institutional standards. Primary endpoint was the compound incidence of postoperative complications. Secondary outcomes included major/minor complications and length of hospital and ICU stay. Results: Of the 1,765 patients, 31.0% were anemic of any cause before surgery. Transfusion rates were 81% in anemic patients and 41.2% in nonanemic patients. The adjusted risks for compound postoperative complication were significantly higher in patients with moderate anemia (OR 4.88, 95% CI: 1.54–13.15, p = 0.003) but not for patients with mild anemia (OR 1.93, 95% CI: 0.85–3.94, p < 0.090). Perioperative ABT was associated with significantly higher risks for complications in nonanemic patients and showed an increased risk for complications in all anemic patients. In RTHS, perioperative ABT as a treatment for moderate preoperative anemia of any cause was associated with a negative compound effect on postoperative complications, compared to anemia or ABT alone. Discussion: ABT is associated with adverse outcomes of patients with moderate preoperative anemia before RTHS. For this reason, medical treatment of moderate preoperative anemia may be considered.
Chronic illness can have a profound impact on couples’ relationships. In dealing with relational changes, new constructions and forms of relationships may arise. In the context of a larger grounded theory study on relational processes and practices in couples faced with chronic illness, this article focuses on concurrent relationships as an alternative form of relationship construction which embodies an additional relationship existing parallel to that of the couple confronted with chronic illness. Based on qualitative interviews with a subsample of five persons within the larger study, conditions for the development and characteristics of concurrent relationships are presented. From an individual and shared life questioned by chronic illness, concurrent relationships are formed in the attempt to be able to live on together in a new partner relationship and a continued care relationship. This can lead to new constructions of relationships, family life, and social relations in everyday life.
Organic pot-based production of basil (Ocimum basilicum L.) often has lower biomass yield than conventional cultivation. Previous investigations indicate that this growth impairment is related to high ammonium (NH4+) concentrations in the growing media released by the mineralization of organic nitrogen (N) fertilizers. However, as a result of this ammonification process substrate pH may also increase. Under neutral to alkaline conditions NH4+ is converted to ammonia (NH3), which is known to be phytotoxic even at low concentrations. Therefore, we investigated the impact of both ammonical N species on basil grown in a peat substrate. In total, three fertilization pot experiments were conducted in a greenhouse in order to compare the effect of different organic base dressings [250 and 750 mg N (L substrate)-1 mainly supplied by a liquid amino acid fertilizer (AAF)] and two initial substrate pH levels (5.5 and 6.5). In two treatments, 5% (v/v) mature compost was mixed into the peat 1 day and 12–days before the substrate was used for sowing, respectively. The aim of this procedure was to stimulate nitrification in this way to reduce ammonical N concentration. Ammonia concentration in the aerial plant surrounding environment was measured by using NH3 detector tubes in combination with an open-top chamber method. The results showed that the growth of basil (number of plants, fresh matter yield, plant height) was significantly inhibited in the second and third week of cultivation by rising NH3 and NH4+ exposure, as well as by a substrate pH ≥ 7.0. These adverse effects were reduced by lowering the organic base dressing rate and adjusting the initial substrate pH to 5.5. Furthermore, the addition of mature compost to peat in combination with a 12-day storage was proven to be effective for promoting nitrification in the organically fertilized substrate. As a result, plant growth was improved by both lower NH3 and NH4+ exposure as well as a faster supply of nitrate (NO3-) as an additional N source. Using this approach, it was possible to feed organically fertilized basil right from the seedling stage with a NO3--N/NH4+-N-balanced and later on providing a predominant NO3--N supply.
The relevance of cross-industry innovation has increased in recent decades with a growing number of inter-industry fields emerging on the borderline between formerly distinct industries. The aim of this paper is to analyse industry convergence in four probiotics innovation value chains based on the following indicators: cross-industry relationships along the innovation value chain as well as knowledge, technological, regulatory and competence convergence. In so doing, the study delivers a framework of indicators for scrutinising industry convergence processes. In order to identify industry convergence, we analyse companies in the converging area of foods and drugs based on products containing the four bacteria strains: Lactobacillus caseii DN 114001, Bifidobacterium lactis Bb12, Lactobacillus acidophilus LA5 and Lactobacillus rhamnosus. Hence, the commercial availability of the strains on the market serves as a selection criterion. Altogether 12 companies stemming from four industrial backgrounds, food and agriculture (5), pharmaceutics (5), chemistry (1) and personal care (1), as well as one research organisation are identified. Cross-industry relationships occur along the innovation value chains of the four strains. Clear signs of knowledge and technological convergence are found as companies are not only publishing and patenting in the usual area of their own industrial field but also in the area of other industrial fields. Companies with different industrial backgrounds show activities in obtaining health claims indicating regulatory convergence. Companies' competence bases seem to converge as companies with different industrial backgrounds are involved in acquisitions, licencing agreements and strategic alliances (competence convergence). We contribute to the existing body of literature by assessing industry convergence from an innovation value chain perspective with a set of indicators reflecting the intensity of industry convergence. This framework of indicators stemming from literature has not yet been used in a combined comprehensive analysis. Furthermore, we tried to show the characteristics of strategic types driving industry convergence in probiotics.
Soil seed banks have a high potential for vegetation re-establishment in restoration projects. We studied the soil seed bank in an oxbow system of a disconnected floodplain of the Danube River in Southern Germany. The aim of the study was to analyze if floodplain target species were still present in the seed bank after more than 150 years of embankment and disconnection from fluvial dynamics. In this context we investigated seed density, seed bank species richness and species composition in four broad habitat types with and without water-level fluctuations during the time of embankment (permanent water, fluctuating water, reed bed, hardwood floodplain forest). In addition, the similarity between seed bank and above-ground vegetation in these habitat types was studied in order to predict the success of future restoration measures. In total, 124 vascular plant species were determined in the seed bank samples. More than 50 % (66 species) were target species typical for floodplain habitats and 26 of these target species were lost or very rare in the above-ground vegetation. The four habitat types differed significantly in mean seed density and mean species richness. Mean species richness and the number of target species in the seed bank as well as the mean seed density were greatest in the habitats with fluctuating water level whereas mean seed density was much lower in the parts with more or less stable conditions like permanently standing water and hardwood floodplain forest. Sørensen similarity between seed bank and above-ground vegetation was very low in habitats with more or less stable water levels and desirable floodplain target species were very rare or completely absent. Our results indicate that the soil seed bank can be an important seed reservoir for the ecological restoration of floodplain plant communities especially for habitats with unstable environmental conditions during the period of disconnection. Restoration of water level dynamics is important to maintain the seed bank of populations of floodplain target species.
Background:
Contact tracing apps are potentially useful tools for supporting national COVID-19 containment strategies. Various national apps with different technical design features have been commissioned and issued by governments worldwide.
Objective:
Our goal was to develop and propose an item set that was suitable for describing and monitoring nationally issued COVID-19 contact tracing apps. This item set could provide a framework for describing the key technical features of such apps and monitoring their use based on widely available information.
Methods:
We used an open-source intelligence approach (OSINT) to access a multitude of publicly available sources and collect data and information regarding the development and use of contact tracing apps in different countries over several months (from June 2020 to January 2021). The collected documents were then iteratively analyzed via content analysis methods. During this process, an initial set of subject areas were refined into categories for evaluation (ie, coherent topics), which were then examined for individual features. These features were paraphrased as items in the form of questions and applied to information materials from a sample of countries (ie, Brazil, China, Finland, France, Germany, Italy, Singapore, South Korea, Spain, and the United Kingdom [England and Wales]). This sample was purposefully selected; our intention was to include the apps of different countries from around the world and to propose a valid item set that can be relatively easily applied by using an OSINT approach.
Results:
Our OSINT approach and subsequent analysis of the collected documents resulted in the definition of the following five main categories and associated subcategories: (1) background information (open-source code, public information, and collaborators); (2) purpose and workflow (secondary data use and warning process design); (3) technical information (protocol, tracing technology, exposure notification system, and interoperability); (4) privacy protection (the entity of trust and anonymity); and (5) availability and use (release date and the number of downloads). Based on this structure, a set of items that constituted the evaluation framework were specified. The application of these items to the 10 selected countries revealed differences, especially with regard to the centralization of the entity of trust and the overall transparency of the apps’ technical makeup.
Conclusions:
We provide a set of criteria for monitoring and evaluating COVID-19 tracing apps that can be easily applied to publicly issued information. The application of these criteria might help governments to identify design features that promote the successful, widespread adoption of COVID-19 tracing apps among target populations and across national boundaries.
Abstract
Background
The clinical presentation of neck-arm pain is heterogeneous with varying underlying pain types (nociceptive/neuropathic/mixed) and pain mechanisms (peripheral/central sensitization). A mechanism-based clinical framework for spinally referred pain has been proposed, which classifies into (1) somatic pain, (2) neural mechanosensitivity, (3) radicular pain, (4) radiculopathy and mixed pain presentations. This study aims to (i) investigate the application of the clinical framework in patients with neck-arm pain, (ii) determine their somatosensory, clinical and psychosocial profile and (iii) observe their clinical course over time.
Method
We describe a study protocol. Patients with unilateral neck-arm pain (n = 180) will undergo a clinical examination, after which they will be classified into subgroups according to the proposed clinical framework. Standardized quantitative sensory testing (QST) measurements will be taken in their main pain area and contralateral side. Participants will have to complete questionnaires to assess function (Neck Disability Index), psychosocial factors (Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Depression, anxiety and stress scale), neuropathic pain (Douleur Neuropathique 4 Questions, PainDETECT Questionnaire) and central sensitization features (Central Sensitization Inventory). Follow-ups at three, six and 12 months include the baseline questionnaires. The differences of QST data and questionnaire outcomes between and within groups will be analyzed using (M)AN(C)OVA and/or regression models. Repeated measurement analysis of variance or a linear mixed model will be used to calculate the differences between three, six, and 12 months outcomes. Multiple regression models will be used to analyze potential predictors for the clinical course.
Conclusion
The rationale for this study is to assess the usability and utility of the proposed clinical framework as well as to identify possible differing somatosensory and psychosocial phenotypes between the subgroups. This could increase our knowledge of the underlying pain mechanisms. The longitudinal analysis may help to assess possible predictors for pain persistency.